OBJECTIVES: In universal health systems, the incorporation of technologies is a complex process requiring thorough studies based on a range of methodologies and guidelines established in the scientific field of Health Technology Assessment (HTA). In Brazil, since 2011, the National Commission for the Incorporation of Technologies (CONITEC) has utilized HTA to evaluate the inclusion of health technologies in the Unified Health System (SUS). Despite the comprehensive steps required for an HTA study, including systematic literature reviews and economic evaluations, adopting a new technology can still present uncertainties, particularly when evidence in the literature is scarce or there are gaps in real-world performance. This study aims to understand the main restrictions imposed by CONITEC on the incorporation of health technologies in Brazil.

METHODS: A search was conducted in the HTA Accelerator database, an IQVIA developed tool that compiles and analyzes publications from 41 countries and over 100 HTA agencies and regulatory bodies. Information provided by CONITEC between 2011 and 2023 was selected to understand the restrictions imposed by Conitec decisions.

RESULTS: The main restriction imposed by CONITEC for the incorporation of medications is the specification of patient characteristics, including the inclusion and exclusion criteria, suggesting an attempt to restrict the target population. Another significant restriction is conditional incorporation linked to post-incorporation data collection, allowing for a re-evaluation of the technology within a set period using national context data. The third most used restriction involves price negotiations.

CONCLUSIONS: The analysis suggests that CONITEC has been structuring restrictions that go beyond just patient inclusion and exclusion criteria or subpopulation specifications. It also employs strategies such as conditional incorporation tied to evidence generation, highlighting a move towards more dynamic and data-driven decision-making processes.